Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit (PICINI)

Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit. Comparative of Cost-Effectiveness and Safety

This study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients.

Study Overview

• Status: Unknown
• Conditions: Infection; Thromboses, Venous; Economic Problems
• Intervention / Treatment: Other: PICC(Peripherally inserted central catheter); Other: CVC(Central venous catheter )

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • Recruiting
      • First Affiliated Hospital of Xian Jiaotong University
      • Contact: Hao Liu, MD; Phone Number: 0086-029-85324005; Email: hao_liu@xjtu.edu.cn
      • Principal Investigator: Hao Liu, MD
      • Sub-Investigator: Wei Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients admitted to the neurosurgical intensive care unit , who require central access for the treatment of their illness.

Exclusion Criteria:

• Insertion of the central catheter in emergency situations;
• Anatomical abnormalities of upper extremity affecting PICC placement;
• Current or recent (within 1 month) diagnosis of bacteremia
• Current or recent (within 1 year with confirmed resolution by imaging) deep venous thrombosis;
• Presence of skin changes in the area of the puncture, such as thrombophlebitis, dermatitis, cellulitis, burn among others;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PICC(Peripherally inserted central catheter); Patients randomly assigned to receive a peripherally inserted central catheter(PICC).	Other: PICC(Peripherally inserted central catheter); The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established.
ACTIVE_COMPARATOR: CVC(Central venous catheter ); Patients randomly assigned to receive a centrally inserted central venous catheter(CVC).	Other: CVC(Central venous catheter ); The central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, using the Seldinger technique. A suitable sterile field will be established.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
thrombotic complications	radiographically-confirmed upper-extremity deep vein thrombosis	up to 30 days or be discharged from hospital
mechanical complications	pneumothorax or hematoma caused by puncture	up to 30 days or be discharged from hospital
infectious complications	catheter related bloodstream infection	up to 30 days or be discharged from hospital

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
catheter replacement	obstruction or accidental removal	up to 30 days or be discharged from hospital
cost effectiveness	The cost of catheter implantation and replacement, as well as the cost of treatment due to catheter-related complications and the resulting financial loss to the patient.	up to 30 days or be discharged from hospital

Collaborators and Investigators

• Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Investigators: Principal Investigator: Hao Liu, MD, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2019
• Primary Completion (ANTICIPATED): December 31, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: April 7, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (ACTUAL): April 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 21, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thrombosis; Venous Thrombosis
• Other Study ID Numbers: XJTU1AF2019LSK-2019-032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No